Regulatory Affairs Manager
Position
Summary:
The Manager Regulatory Affairs is responsible for the overall regulatory affairs management in order to remain in compliance with FDA, and all other U.S. and international regulatory requirements for Medical Devices and/or In-Vitro Diagnostics product where they are registered or are to be registered.The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements.This position is also a customer facing role and will require excellent interpersonal and communication skills in addition to attention to detail and a strong sense of urgency.Business Overview:
The Regulatory Affairs Manager is part of the Clinical Diagnostics business unit (CDR) within our Clinical Diagnostics Division (CDD).CDR provides end-to-end customer solutions to establish manufacturing process and routine supply for a wide range of diagnostic reagents across multiple disciplines including immunoassay, clinical chemistry, hematology and molecular diagnostics.The majority of the business is the supply of products that are manufactured on an OEM basis for the global leaders of the in vitro diagnostic industry. The business unit has employees at multiple global locations with dedicated manufacturing facilities in Middletown and a small, but rapidly growing satellite organization in Suzhou, China.Key
Responsibilities:
Coordinates and supports submissions to FDA and other Regulatory Agencies, including International Authorities.Ensure rapid and timely approval of new products and continued Regulatory support of marketed products.Regulatory expert to support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.Partners with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.Prepares and/or reviews documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, and technical files for CE marking.Prepares and/or compiles information required by ex-U.S. regulatory associates to support registration or licensing products outside the U.S.Reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.Provides regulatory advice to project teams.Acts as Regulatory lead for Regulatory activities related to contact manufacturing activity.Creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects and provides the approved plans to design history files as required.Evaluates proposed product modifications for Regulatory impact on a world-wide basis and recommends DHF updates s needed.Completes Regulatory Assessments as needed.Ensures compliance with regulatory agency regulations and interpretations.Submits responses to regulatory agencies' questions and other correspondence.Provides solutions to extreme complex problems.Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.Keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes.Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations, as needed.Reviews and provides regulatory authorization related to ongoing product design changes and field action investigations.Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values.Hire, train and develop Regulatory Affairs staff to ensure high performance and continuity of staffing.Identify high performers and create development plans to prepare them for additional responsibilities and contributions.Act as resource during FDA inspections, Notified Body, customer audits and other third party Quality System evaluations.Minimum Requirements/
Qualifications:
A minimum of a Bachelor's Degree is required, preferably in a scientific discipline.Approximate experience of 10
years in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 8 years of regulatory experience in the medical device and/or pharmaceutical industry is required. Clinical Chemistry experience is preferred.Solid knowledge of US FDA regulations and review processes are required.Practical experience in a medical device Regulatory Environment, preparing US submissions and a successful track record are required.Technical Documentation experience is required.Experience interacting with US FDA and other country Regulatory Agencies is required.Experience in European Union, Asia/Pacific and South American regulations and submissions is preferred.Professional written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.Being detail-oriented, while having the ability to handle multiple ongoing projects/tasks is required.Practical application of when to be firm with decision and answers verses flexible to assure complianceExperience in IVD Regulation and good understanding of IVD Regulation.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Manager Regulatory Affairs is responsible for the overall regulatory affairs management in order to remain in compliance with FDA, and all other U.S. and international regulatory requirements for Medical Devices and/or In-Vitro Diagnostics product where they are registered or are to be registered.The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements.This position is also a customer facing role and will require excellent interpersonal and communication skills in addition to attention to detail and a strong sense of urgency.Business Overview:
The Regulatory Affairs Manager is part of the Clinical Diagnostics business unit (CDR) within our Clinical Diagnostics Division (CDD).CDR provides end-to-end customer solutions to establish manufacturing process and routine supply for a wide range of diagnostic reagents across multiple disciplines including immunoassay, clinical chemistry, hematology and molecular diagnostics.The majority of the business is the supply of products that are manufactured on an OEM basis for the global leaders of the in vitro diagnostic industry. The business unit has employees at multiple global locations with dedicated manufacturing facilities in Middletown and a small, but rapidly growing satellite organization in Suzhou, China.Key
Responsibilities:
Coordinates and supports submissions to FDA and other Regulatory Agencies, including International Authorities.Ensure rapid and timely approval of new products and continued Regulatory support of marketed products.Regulatory expert to support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.Partners with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.Prepares and/or reviews documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, and technical files for CE marking.Prepares and/or compiles information required by ex-U.S. regulatory associates to support registration or licensing products outside the U.S.Reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.Provides regulatory advice to project teams.Acts as Regulatory lead for Regulatory activities related to contact manufacturing activity.Creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects and provides the approved plans to design history files as required.Evaluates proposed product modifications for Regulatory impact on a world-wide basis and recommends DHF updates s needed.Completes Regulatory Assessments as needed.Ensures compliance with regulatory agency regulations and interpretations.Submits responses to regulatory agencies' questions and other correspondence.Provides solutions to extreme complex problems.Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.Keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes.Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations, as needed.Reviews and provides regulatory authorization related to ongoing product design changes and field action investigations.Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values.Hire, train and develop Regulatory Affairs staff to ensure high performance and continuity of staffing.Identify high performers and create development plans to prepare them for additional responsibilities and contributions.Act as resource during FDA inspections, Notified Body, customer audits and other third party Quality System evaluations.Minimum Requirements/
Qualifications:
A minimum of a Bachelor's Degree is required, preferably in a scientific discipline.Approximate experience of 10
years in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 8 years of regulatory experience in the medical device and/or pharmaceutical industry is required. Clinical Chemistry experience is preferred.Solid knowledge of US FDA regulations and review processes are required.Practical experience in a medical device Regulatory Environment, preparing US submissions and a successful track record are required.Technical Documentation experience is required.Experience interacting with US FDA and other country Regulatory Agencies is required.Experience in European Union, Asia/Pacific and South American regulations and submissions is preferred.Professional written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.Being detail-oriented, while having the ability to handle multiple ongoing projects/tasks is required.Practical application of when to be firm with decision and answers verses flexible to assure complianceExperience in IVD Regulation and good understanding of IVD Regulation.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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